The non-alcoholic steatohepatitis (NASH) drug-development race poses many variables, including which endpoint to pursue in pivotal studies. Gilead Sciences Inc. confirmed how challenging this can be by choosing to demonstrate a fibrosis benefit in very sick patients with its candidate selonsertib, which failed by this measure in a Phase III clinical trial.
In NASH, Gilead Swung For The Fences And Struck Out Again
Gilead took a risky approach with selonsertib in NASH, pursuing a tough liver fibrosis benefit and failing, continuing a trend of disappointments outside of its antiviral franchises. Analysts don’t expect the second Phase III study in less-sick patients to succeed either.
More from Clinical Trials
• By
With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.
• By
Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.
• By
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
• By
After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.
More from R&D
• By
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.
• By
The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.
• By
The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.